Investigating the effect of foot reflexology massage on the respiratory pattern of children hospitalized with diabetic ketoacidosis
Design
This is a randomized clinical trial with a parallel design and a control group. This randomized, non-blinded study will be conducted on 30 children with diabetic ketoacidosis. A simple random method is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
In this study, before starting the intervention, in order to perform the massage, first take off the jewelry, wash the hands carefully, and warm them by rubbing them together. Baby oil will be used to reduce friction
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children diagnosed with diabetic ketoacidosis
Exclusion criteria: Nausea and vomiting
Serum sodium level between 145-135 milliequivalent per liter
Intervention groups
In the intervention group, each foot will be massaged five times a day for fifteen minutes. A small pillow will be placed under the child's foot and the child's feet will be ready to be massaged with opening movements. Then thumb and finger techniques will be used to massage the soles and fingers. The control group will not receive any intervention.
Main outcome variables
Pattern of Breathing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N202
Registration date:2023-06-18, 1402/03/28
Registration timing:prospective
Last update:2023-06-18, 1402/03/28
Update count:0
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of foot reflexology massage on the breathing pattern of children with diabetic ketoacidosis
Public title
Investigating the effect of foot reflexology massage on the breathing pattern of children with diabetic ketoacidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children diagnosed with diabetic ketoacidosis
Exclusion criteria:
Nausea and vomiting
Serum sodium level between 145-135 milliequivalent liters
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method. Children with even file numbers will be selected as the intervention group and children with odd file numbers will be selected as the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.018
Health conditions studied
1
Description of health condition studied
Diabetic Ketoacidosis
ICD-10 code
E10-E14:1
ICD-10 code description
Diabetes mellitus with ketoacidosis
Primary outcomes
1
Description
Pattern of Breathing
Timepoint
The beginning of the study and the end of the study
Method of measurement
Counting the number of breaths per minute by the doctor
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, each foot will be massaged five times a day for fifteen minutes. A small pillow will be placed under the child's foot and the child's feet will be ready to be massaged with opening movements. Then thumb and finger techniques will be used to massage the soles and fingers.
Category
Treatment - Other
2
Description
The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Narges Sadeghi
Street address
Imam Khomeini Street, in front of Esteghlal Square, Imam Hossein Children's Educational Therapy Center
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
narges.sadeghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Khorasgan branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Narges Sadeghi
Position
Member of the academic staff of Islamic Azad University, Khorasgan branch
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
narges.sadeghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Narges Sadeghi
Position
Member of the academic staff of Islamic Azad University, Khorasgan branch
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
narges.sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Narges Sadeghi
Position
Member of the academic staff of Islamic Azad University, Khorasgan branch
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
narges.sadeghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD